Biosimilars are biologic products that are highly similar to a licensed reference product in terms of quality, safety, and efficacy. SB5 is a biosimilar of Humira® (adalimumab) developed by Samsung Bioepis. To demonstrate its biosimilarity in quality to Humira®, we performed a comprehensive characterization in terms of structure, physicochemical properties, and biological properties following the International Conference on Harmonization, US Food and Drug Administration, and European Medicines Agency guidelines. We analyzed all available batches of SB5 and more than 100 EU- and US-sourced lots of Humira® using state-of-the-art methods whenever possible, and compared the two sets of data. The structural properties comprised primary and higher-order structures and N-glycosylation. The physicochemical characteristics were categorized into liquid chromatographic patterns and electrophoretic pattern concerning size and charge heterogeneity. The biological properties were examined by in vitro functional assays.Overall, SB5 and Humira® were shown to be similar to each other in terms of quality attributes. For some of the quality attributes, minor differences were observed. However, the observed differences have been adequately addressed and demonstrated these do not translate into clinically meaningful differences in terms of safety, purity, and potency.

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Background: Wearable devices for robot-assisted gait training (RAGT) provide overground gait training for the rehabilitation of neurological injuries. We aimed to evaluate the effectiveness and safety of RAGT in patients with a neurologic deficit. Methods: Twenty-eight patients receiving more than ten sessions of overground RAGT using a joint-torque-assisting wearable exoskeletal robot were retrospectively analyzed in this study. Nineteen patients with brain injury, seven patients with spinal cord injury and two patients with peripheral nerve injury were included. Clinical outcomes, such as the Medical Research Council scale for muscle strength, Berg balance scale, functional ambulation category, trunk control tests, and Fugl–Meyer motor assessment of the lower extremities, were recorded before and after RAGT. Parameters for RAGT and adverse events were also recorded. Results: The Medical Research Council scale scores for muscle strength (36.6 to 37.8), Berg balance scale (24.9 to 32.2), and functional ambulation category (1.8 to 2.7) significantly improved after overground RAGT (p < 0.05). The familiarization process was completed within six sessions of RAGT. Only two mild adverse events were reported. Conclusions: Overground RAGT using wearable devices can improve muscle strength, balance, and gait function. It is safe in patients with neurologic injury.

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